AE Reporting

• Check the ADT notifications on EPIC daily.

• SAEs especially are required to be reported within a certain time frame (usually 24-48 hours), so, if you expect to be out on leave for an extended time, make sure to have someone help you monitor for AEs.

• Also, you can absolutely report with incomplete information. It is better to report asap.

• Some studies require only SAEs (and not non-serious AEs) to be reported after a certain time point in the study.

• When in doubt, always report first. Worse thing that can come from that is, the sponsor then later contacts you to delete the AE.

• AE Adjudication: the enrolling investigator needs to evaluate all AEs for the patient and determine a few things like, severity, relationship to the study, device, etc.

  • The "gold standard" is to ask them for all the information before entering the data into the EDC. However, sometimes it is blatantly obvious that an AE is not related (e.g. patient getting hospitalized for a car crash injury 4 years after receiving a stent in their leg), so if the sponsor pesters you, exercise discretion and report that information.